Micronutrient-supplemented Milk Study in Women of Childbearing Age

Overview

The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk product) over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2013

Detailed Description

Folic acid (~400 µg/day) taken around the time of conception significantly reduces the risk of a neural tube defect (NTD)-affected pregnancy. Strategies to reduce NTD with folic acid, include supplement use and food fortification. An attractive strategy for NTD prevention is the use of fortified foods targeted for use by women planning a pregnancy. Fonterra currently markets a fortified-milk (ANMUM Materna) in Asia, designed for use prior to and during pregnancy. This milk product, if consumed as directed, provides ~400 µg folic acid per day. It is not known whether ANMUM Materna will reduce NTD rate. However, in a case-control study the risk of NTD was inversely associated with maternal red blood cell (RBC) folate concentrations. Accordingly, if ANMUM Materna increases RBC folate, it could be expected to decrease NTD risk. In this study, the ANMUM Materna fortified milk will be tested against a standard control (unfortified) milk over a 12 week period. The subjects will consume 75g of milk powder daily throughout the supplementation period.

Interventions

  • Dietary Supplement: ANMUM Materna
  • Dietary Supplement: Control (milk powder)

Arms, Groups and Cohorts

  • Active Comparator: ANMUM Materna
    • 75g milk powder in 400 ml water daily for 12 weeks.
  • Placebo Comparator: Control
    • 75g of milk powder in 400 ml water for 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Increase in red blood cell folate concentration
    • Time Frame: 12 weeks
    • To determine if consuming ANMUM Materna over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.

Secondary Measures

  • Reduction in homocysteine concentration
    • Time Frame: 12 weeks
    • To determine if consuming ANMUM Materna over a 12-week period lowers homocysteine concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.
  • Increase in plasma folate concentration
    • Time Frame: 12 weeks
    • To determine if consuming ANMUM Materna over a 12-week period increases plasma folate concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.
  • Increase in plasma vitamin B12 concentration
    • Time Frame: 12 weeks
    • To determine if consuming ANMUM over a 12-week period increases plasma vitamin B12 concentrations in women of childbearing age, compared to an equivalent amount of standard (unfortified) milk.

Participating in This Clinical Trial

Inclusion Criteria

  • Female 21-35 years old. – Able to understand the nature and purpose of the study, including potential risks and side effects. – Willing to consent to study participation and to comply with study requirements. – Negative Pregnancy test at screening Exclusion Criteria:

  • Consumption of vitamins and/or mineral supplements known to contain folate 6 months prior. – Chronic disease. – Milk and/or lactose-intolerant. – Pregnancy in the last 12 months, or currently planning a pregnancy. – Prior history of NTD-affected pregnancy – Serum Folate deficiency

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fonterra Research Centre
  • Collaborator
    • Changi General Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Magdalin Cheong, Principal Investigator, Changi General Hospital

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